Monday, January 30, 2017

Dr. Berger brings 20 years of drug development experience highlighted by the FDA approvals of Mylotarg® for acute myeloid leukemia, the only drug approved in AML in several decades, and Tykerb® for breast cancer

Dr.
Dragan Cicic appointed to newly created position of Chief Technical
Officer to execute on pipeline expansion and strategic initiatives

Actinium Pharmaceuticals,
Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical
company developing innovative targeted therapies for cancers lacking
effective treatment options, announced that Dr. Mark Berger has been
appointed Chief Medical Officer effective today. Dr. Berger joins
Actinium with significant drug development expertise that includes the
planning and execution of clinical trials that led to the FDA approval
of Mylotarg for acute myeloid leukemia (AML) while at Wyeth Research
(now Pfizer), and Tykerb for breast cancer while at GlaxoSmithKline. He
also has experience in patient care and lab-based cancer research. Dr.
Berger will report to Sandesh Seth, Actinium’s Executive Chairman.

“Dr.
Berger has a stellar track record in hematology/oncology research and
drug development that makes him perfectly suited for the position of
Chief Medical Officer at Actinium,” said Sandesh Seth. “Dr. Berger led
the development of Mylotarg, which like Actimab-A, is a CD33 targeting
agent. Mylotarg remains the only drug approved in AML in the last
several decades, and Dr. Berger was integral to Mylotarg’s approval as
highlighted by his presentation to ODAC. This along with Mark’s many
other accomplishments in drug development, medical training and research
experience gives us great confidence in his ability to build a robust
clinical development organization to execute on the clinical development
of Iomab-B, Actimab-A and our future clinical programs.”

“I
am impressed with the potential for Actinium’s radioimmunotherapy
technology,” Dr. Berger said. “The data to date on Iomab-B and Actimab-A
are very compelling and suggest that radioimmunotherapy has the
potential to be safe and effective particularly in difficult clinical
indications such as bone marrow transplant conditioning in patients with
AML, or in the treatment of older patients with AML. I am excited to
join the Actinium team and look forward to executing on a clinical
development strategy that will bring these therapies to approval.”

In
addition, Dr. Dragan Cicic, Actinium’s previous Chief Medical Officer,
has been appointed to the newly created position of Chief Technology
Officer. In his new role, Dr. Cicic will be responsible for leveraging
Actinium’s alpha particle immunotherapy (APIT) technology platform to
further expand Actinium’s clinical pipeline. Dr. Cicic will also be
responsible for driving strategic initiatives including research
collaborations and partnerships as well as continuing to expand
relationships with the medical and scientific communities.

“Actinium’s
growth and progress particularly in 2016 has been transformative and
Dr. Berger’s joining is a continued step in that direction,” said Dr.
Cicic. “I am excited to work with Dr. Berger and am confident that he
will have a lasting impact on the execution of our late stage clinical
trials. I welcome my new responsibilities and look forward to having the
opportunity to focus extensively on our APIT platform to create value
by laying the groundwork for new clinical programs and through strategic
initiatives.”

Dr. Berger joins Actinium from
Kadmon Corporation where he was Senior Vice President, Clinical
Research. In this role he was responsible for all clinical aspects of
new drug development including designing and managing clinical trials in
oncology indications (non-small cell lung cancer and glioblastoma) and
non-oncology indications (chronic graft versus host disease and
polycystic kidney disease). Dr. Berger joined Kadmon after serving as
Chief Medical Officer of Deciphera Pharmaceuticals. Prior to Deciphera,
Dr. Berger was Vice President for Clinical Development at Gemin X
Pharmaceuticals where he led the clinical strategy, design and
management of clinical trials for two novel oncology agents including
obatoclax, a pan Bcl-2 inhibitor. Based on the results of a randomized
Phase 2 clinical trial of obatoclax, Gemin X was acquired by Cephalon in
March of 2011 for a total consideration of $525 million including $225
million in an upfront cash payment.

Before his work
with biotechnology companies, Dr. Berger held key positions in two
global pharmaceutical companies. Dr. Berger previously served as Group
Director, Medicine Development Centre-Oncology for GlaxoSmithKline. In
this position Dr. Berger managed the development of Tykerb (lapatinib)
in lung and breast cancer where he designed and led two Phase 2 clinical
trials before planning and leading a 399 patient pivotal Phase 3 trial
that resulted in the FDA approval of Tykerb in breast cancer. In
addition, he managed the Lapatinib Expanded Access Program (LEAP) that
enrolled over 4000 patients on a global basis. Dr. Berger began his
career in drug development at Wyeth Research where he led the planning
and execution of the pivotal Phase 2 trial for Mylotarg, which was the
first antibody targeted chemotherapy agent and targeted CD33, similar to
Actimab-A. He presented the Mylotarg clinical data at the FDA’s
Oncology Drug Advisory Committee meeting, after which Mylotarg received
accelerated FDA approval for patients with relapsed AML.

Dr.
Berger has a B.A. in biology from Wesleyan University and received his
M.D. from the University of Virginia School of Medicine. He did his
Hematology-Oncology fellowship at the University of Pennsylvania where
he was an Assistant Professor of Medicine, and also was a Research
Fellow at the Ludwig Institute for Cancer Research and the Imperial
Cancer Research Fund, both in London. Dr. Berger is board certified in
internal medicine, hematology and medical oncology.

About Actinium Pharmaceuticals, Inc.

Actinium
Pharmaceuticals, Inc. is a biopharmaceutical company developing
innovative targeted therapies for patients with cancers lacking
effective treatment options. Actinium's proprietary platform utilizes
monoclonal antibodies to deliver radioisotopes directly to cells of
interest in order to kill those cells safely and effectively. The
Company's lead product candidate Iomab-B is designed to be used, upon
approval, in preparing patients for a hematopoietic stem cell
transplant, commonly referred to as bone marrow transplant. A bone
marrow transplant is often the only potential cure for patients with
blood-borne cancers but the current standard preparation for a
transplant requires chemotherapy and/or total body irradiation that
result in significant toxicities. Actinium believes Iomab-B will enable a
faster and less toxic preparation of patients seeking a bone marrow
transplant, leading to increased transplant success and survival rates.
The Company is currently conducting a single pivotal 150-patient,
multicenter Phase 3 clinical study of Iomab-B in patients with relapsed
or refractory acute myeloid leukemia (AML) age 55 and older. The
Company's second product candidate, Actimab-A, is currently in a
multicenter open-label, 53-patient Phase 2 trial for patients newly
diagnosed with AML age 60 and over. Actimab-A is being developed to
induce remissions in elderly patients with AML who lack effective
treatment options and often cannot tolerate the toxicities of standard
frontline therapies. Actinium is also utilizing its alpha-particle
immunotherapy (APIT) technology platform to generate new drug candidates
based on antibodies linked to the element Actinium-225 that are
directed at various cancers that are blood-borne or form solid tumors.
Actinium Pharmaceuticals is based in New York, NY. To learn more about
Actinium Pharmaceuticals, please visit www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, www.twitter.com/actiniumpharma.

- Dr. Larrieux brings significant
experience managing analytical development quality control of
immunotherapies to treat cancer and small molecule therapies at
pharmaceutical and biotechnology organizations

“Dr.
Larrieux is an accomplished analytical professional who is bringing
over 20 years of highly relevant industry experience in matters related
to regulatory submissions, project management and QA/QC to Actinium,”
said Sandesh Seth, Actinium’s Executive Chairman. “Dr. Larrieux is yet
another invaluable addition to the Actinium team that will contribute
enormously to the development of our clinical programs Iomab-B and
Actimab-A as well as future clinical programs we hope to unveil in the
near future.”

Dr. Larrieux joins Actinium
following analytical consulting assignments in the U.S. and Europe.
Prior to this, she was Head of AS&T at Novartis where she focused on
cell therapy products aimed to treat acute lymphoblastic leukemia (ALL)
and chronic lymphocytic leukemia (CLL). Prior to Novartis, Dr. Larrieux
was Laboratory Manager at Dendreon Corporation where she supported
Phase 3 and Phase 4 clinical studies. In addition, Dr. Larrieux has
worked at Pfizer, Purdue Pharma and Wyeth in analytical roles.

Dr.
Larrieux earned her Ph.D. in Material Chemistry from Polytechnic
Institute of NYU, an M.S. degree in Chemistry from Polytechnic
University and a BS.c. degree in Chemistry from State University of
HAITI (PAP). In addition, she is a member of the Regulatory Affairs
Professionals Society (RAPS) and a member of the American Society for
Quality (ASQ).

About Actinium Pharmaceuticals, Inc.

Actinium
Pharmaceuticals, Inc. is a biopharmaceutical company developing
innovative targeted therapies for patients with cancers lacking
effective treatment options. Actinium's proprietary platform utilizes
monoclonal antibodies to deliver radioisotopes directly to cells of
interest in order to kill those cells safely and effectively. The
Company's lead product candidate Iomab-B is designed to be used, upon
approval, in preparing patients for a hematopoietic stem cell
transplant, commonly referred to as bone marrow transplant. A bone
marrow transplant is often the only potential cure for patients with
blood-borne cancers but the current standard preparation for a
transplant requires chemotherapy and/or total body irradiation that
result in significant toxicities. Actinium believes Iomab-B will enable a
faster and less toxic preparation of patients seeking a bone marrow
transplant, leading to increased transplant success and survival rates.
The Company is currently conducting a single pivotal 150-patient,
multicenter Phase 3 clinical study of Iomab-B in patients with relapsed
or refractory acute myeloid leukemia (AML) age 55 and older. The
Company's second product candidate, Actimab-A, is currently in a
multicenter open-label, 53-patient Phase 2 trial for patients newly
diagnosed with AML age 60 and over. Actimab-A is being developed to
induce remissions in elderly patients with AML who lack effective
treatment options and often cannot tolerate the toxicities of standard
frontline therapies. Actinium is also utilizing its alpha-particle
immunotherapy (APIT) technology platform to generate new drug candidates
based on antibodies linked to the element Actinium-225 that are
directed at various cancers that are blood-borne or form solid tumors.
Actinium Pharmaceuticals is based in New York, NY. To learn more about
Actinium Pharmaceuticals, please visit www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, www.twitter.com/actiniumpharma.

- Orphan Designation in the EU can result in regulatory assistance, reduced fees and 10 years of market exclusivity

Actinium
Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a
biopharmaceutical company developing innovative targeted therapies for
cancers lacking effective treatment options, announced today that the
Company has submitted an application with the European Medicines Agency
(EMA) seeking Orphan Designation for Actimab-A for patients newly
diagnosed with acute myeloid leukemia (AML) age 60 and above who are
ineligible for currently used induction therapies. Actimab-A is
currently in a 53-patient, multicenter open label Phase 2 trial where it
is being studied as a monotherapy in these patients who have low
peripheral blast (PB) burden. In a previously completed Phase 1 trial,
Actimab-A showed a 50% composite response rate at the dose level of 2.0
μCi/kg/fraction, which is the dose level being studied in the current
Phase 2 trial, in patients with low PB burden.

“Orphan
designation brings significant benefits to the drug development
process,” said Sandesh Seth, Executive Chairman of Actinium
Pharmaceuticals. “We are excited to have submitted this application with
the EMA and we are optimistic that Actimab-A will soon have orphan
designation in the EU just as it does in the U.S. If this were to occur,
both of our clinical product candidates, Iomab-B and Actimab-A, would
have orphan designation in the U.S. and EU, which are the largest
addressable markets for our product candidates.”

About EU Orphan Designation

The
EMA, through its Committee for Orphan Medicinal Products (COMP),
examines applications for orphan designation. To qualify for orphan
designation, the prevalence of the condition must be less than 5 in
10,000, it must be life threatening or chronically debilitating and
there must be no satisfactory method of treating the condition. Sponsors
who obtain orphan designation receive numerous incentives including
protocol assistance, a reduction or waving of fees and 10 years of
market exclusivity should the therapy be approved. The process of filing
and receiving the orphan medicines designation can take between eight
to fourteen months in most cases. To learn more please visit EMA’s COMP
website http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000263.jsp&mid=WC0b01ac0580028e30.

About Actimab-A

Actimab-A,
Actinium's most advanced alpha particle immunotherapy (APIT) product
candidate, is currently in a 53-patient, multicenter Phase 2 trial for
patients newly diagnosed with AML age 60 and above. Actimab-A is being
developed as a first-line therapy and is a monotherapy that is
administered via two 15-minute injections that are given 7 days apart.
Actimab-A targets CD33, a protein abundantly expressed on the surface of
AML cells via the monoclonal antibody, HuM195, which carries the potent
cytotoxic radioisotope actinium-225 to the AML cancer calls.
Actinium-225 gives off high-energy alpha particles as it decays, which
kill cancer cells and as actinium-225 decays it produces a series of
daughter atoms, each of which gives off its own alpha particle,
increasing the chances that the cancer cell will be destroyed. Actimab-A
is a second-generation therapy from the Company’s HuM195-Alpha program,
which was developed at Memorial Sloan Kettering Cancer Center and has
now been studied in almost 90 patients in four clinical trials.
Actimab-A has been granted Orphan Drug Designation for newly diagnosed
AML age 60 and above.

About Actinium Pharmaceuticals, Inc.

Actinium
Pharmaceuticals, Inc. is a biopharmaceutical company developing
innovative targeted therapies for patients with cancers lacking
effective treatment options. Actinium's proprietary platform utilizes
monoclonal antibodies to deliver radioisotopes directly to cells of
interest in order to kill those cells safely and effectively. The
Company's lead product candidate Iomab-B is designed to be used, upon
approval, in preparing patients for a hematopoietic stem cell
transplant, commonly referred to as bone marrow transplant. A bone
marrow transplant is often the only potential cure for patients with
blood-borne cancers but the current standard preparation for a
transplant requires chemotherapy and/or total body irradiation that
result in significant toxicities. Actinium believes Iomab-B will enable a
faster and less toxic preparation of patients seeking a bone marrow
transplant, leading to increased transplant success and survival rates.
The Company is currently conducting a single pivotal 150-patient,
multicenter Phase 3 clinical study of Iomab-B in patients with relapsed
or refractory acute myeloid leukemia (AML) age 55 and older. The
Company's second product candidate, Actimab-A, is currently in a
multicenter open-label, 53-patient Phase 2 trial for patients newly
diagnosed with AML age 60 and over. Actimab-A is being developed to
induce remissions in elderly patients with AML who lack effective
treatment options and often cannot tolerate the toxicities of standard
frontline therapies. Actinium is also utilizing its alpha-particle
immunotherapy (APIT) technology platform to generate new drug candidates
based on antibodies linked to the element Actinium-225 that are
directed at various cancers that are blood-borne or form solid tumors.
Actinium Pharmaceuticals is based in New York, NY. To learn more about
Actinium Pharmaceuticals, please visit www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, www.twitter.com/actiniumpharma.

Actinium
Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a
biopharmaceutical company developing innovative targeted therapies for
cancers lacking effective treatment options, announced today that
results from its Phase 1 trial of Actimab-A were presented at the 58th
American Society of Hematology Annual Meeting (ASH) that is currently
ongoing in San Diego, CA. Data from the previously conducted Phase 1
study pertaining to safety, efficacy and PB burden were highlighted
during the poster session. Actimab-A is currently being studied in a
53-patient Phase 2 clinical trial as a monotherapy for patients newly
diagnosed with Acute Myeloid Leukemia (AML) age 60 and above who are
ineligible for currently used induction therapies. The Phase 2 trial is
studying Actimab-A as a monotherapy administered via two fifteen minute
intravenous injections of 2.0 μCi/kg/fraction of Actimab-A given a week
apart. PB burden below 200 blasts/µL will serve as an inclusion criteria
and patients above this threshold will be administered hydroxyurea to
reduce their peripheral blasts counts prior to Actimab-A administration.
Results from the Phase 1 trial showed that patients with PB burden
below 200 blasts/µL who received a dose of 2.0 μCi/kg/fraction of
Actimab-A saw a 50% response rate.

Actinium’s PB
burden hypothesis states that patients below the key threshold level of
200 blasts/µL have an increased response rate to Actimab-A while
patients above the key threshold are unlikely to respond. An analysis of
2 clinical trials with Actimab-A totaling 38 patients, of which 36 were
evaluable, showed that 42% (8 of 19) of patients with blasts counts
below 200/µL responded to Actimab-A while no patients with blast counts
above 200/µL responded to Actimab-A. The Phase 1 trial was a dose
escalation study using a 3+3 design. Dose escalation proceeded if
dose-limiting toxicities (DLT) were seen in less than 33% of patients.
Maximum tolerable dose (MTD) was not reached in the Phase 1 trial.

Dr.
Joseph Jurcic, Director of Hematologic Malignancies and Professor of
Medicine at Columbia University Medical Center and Principal
Investigator of the study said, “Older patients with AML, particularly
those that have progressed from MDS, are difficult to treat and have
very few treatment options since many have already received
lower-intensity therapy with hypomethylating agents. The results from
this Phase 1 trial were encouraging in regards to both the safety and
efficacy of Actimab-A. We are particularly excited to have identified
that patients with peripheral blasts below 200/µL have higher response
rates to Actimab-A and that we can reduce blast counts in patients above
that level using hydroxyurea. Actimab-A has shown promise in older AML
patients, including those previously treated for MDS--a population
excluded from trials with most novel agents, including ongoing studies
with other CD33-directed therapies. We look forward to continuing to
study Actimab-A in the ongoing Phase 2 trial and potentially meeting
this critical need.”

Of the 18 patients in the
Phase 1 trial, 28% (5 of 18) had objective responses (2 CR, 1CRp and 2
CRi). Amongst patients with objective responses, median response
duration was 9.1 months (range, 4.1-16.9 months). At the 3 highest dose
levels in the Phase 1 trial (1.0 μCi/kg/fraction - 2.0 μCi/kg/fraction)
objective responses were seen in 33% of patients (5 of 15). Mean bone
marrow blast reduction amongst evaluable patients was 66% with 57% of
patients having bone marrow blast reduction of 50% or greater and 79% of
patients (11 of 14) had bone marrow blast reductions after Cycle 1 of
therapy. The Phase 1 trial enrolled patients newly diagnosed with AML
who are age 60 and above who were administered Actimab-A in combination
with low-dose Cytarabine. Median patient age was 77 with 67% of patients
having prior myelodysplastic syndrome (MDS) of which, 83% received
prior therapy consisting of either hypomethylating agents (HMAs) or a
hematopoietic stem cell transplant (HSCT).

A
formal interim analysis will occur after 31 patients receive Actimab-A,
which the Company expects to occur in mid-2017. The Company anticipates
the Phase 2 trial to be complete by the end of 2017.

“Actimab-A,
given its benign toxicity profile combined with potent efficacy as
evidenced by the results presented today along with its ease of
administration via 2 injections, represents an exciting therapy for
elderly patients with AML,” said Sandesh Seth, Executive Chairman of
Actinium. “Due to our peripheral blast burden hypothesis and optimized
Phase 2 protocol we have great excitement for the current Phase 2
clinical trial and future development pathways for Actimab-A.”

About Actimab-A

Actimab-A,
Actinium's most advanced alpha particle immunotherapy (APIT) product
candidate, is currently in a 53-patient, multicenter Phase 2 trial for
patients newly diagnosed with AML age 60 and above. Actimab-A is being
developed as a first-line therapy and is a monotherapy that is
administered via two 15-minute injections that are given 7 days apart.
Actimab-A targets CD33, a protein abundantly expressed on the surface of
AML cells via the monoclonal antibody, HuM195, which carries the potent
cytotoxic radioisotope actinium-225 to the AML cancer calls.
Actinium-225 gives off high-energy alpha particles as it decays, which
kill cancer cells and as actinium-225 decays it produces a series of
daughter atoms, each of which gives off its own alpha particle,
increasing the chances that the cancer cell will be destroyed. Actimab-A
is a second-generation therapy from the Company’s HuM195-Alpha program,
which was developed at Memorial Sloan Kettering Cancer Center and has
now been studied in almost 90 patients in four clinical trials.
Actimab-A has been granted Orphan Drug Designation for newly diagnosed
AML age 60 and above.

About Actinium Pharmaceuticals, Inc.

Actinium
Pharmaceuticals, Inc. is a biopharmaceutical company developing
innovative targeted therapies for patients with cancers lacking
effective treatment options. Actinium's proprietary platform utilizes
monoclonal antibodies to deliver radioisotopes directly to cells of
interest in order to kill those cells safely and effectively. The
Company's lead product candidate Iomab-B is designed to be used, upon
approval, in preparing patients for a hematopoietic stem cell
transplant, commonly referred to as bone marrow transplant. A bone
marrow transplant is often the only potential cure for patients with
blood-borne cancers but the current standard preparation for a
transplant requires chemotherapy and/or total body irradiation that
result in significant toxicities. Actinium believes Iomab-B will enable a
faster and less toxic preparation of patients seeking a bone marrow
transplant, leading to increased transplant success and survival rates.
The Company is currently conducting a single pivotal 150-patient,
multicenter Phase 3 clinical study of Iomab-B in patients with relapsed
or refractory acute myeloid leukemia (AML) age 55 and older. The
Company's second product candidate, Actimab-A, is currently in a
multicenter open-label, 53-patient Phase 2 trial for patients newly
diagnosed with AML age 60 and over. Actimab-A is being developed to
induce remissions in elderly patients with AML who lack effective
treatment options and often cannot tolerate the toxicities of standard
frontline therapies. Actinium is also utilizing its alpha-particle
immunotherapy (APIT) technology platform to generate new drug candidates
based on antibodies linked to the element Actinium-225 that are
directed at various cancers that are blood-borne or form solid tumors.
Actinium Pharmaceuticals is based in New York, NY. To learn more about
Actinium Pharmaceuticals, please visit www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, www.twitter.com/actiniumpharma.

Director of Clinical Operations brings
nearly two decades of clinical development and pharmaceutical industry
experience to Actinium

Actinium
Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a
biopharmaceutical Company developing innovative targeted payload
immunotherapeutics for the treatment of advanced cancers, announced
today the appointment of Gregory Bergonio, M.S.H.S., to the position of
Director of Clinical Operations. Mr. Bergonio’s initial responsibility
will be focusing on the advancement of the Actimab-A Phase 2 clinical
trial as well as earlier stage clinical programs that the company plans
to undertake.

“We are very excited to
welcome Greg to the clinical development team at Actinium,” said Sandesh
Seth, Actinium’s Executive Chairman. “Greg’s joining comes at an ideal
time given our increased development efforts as a result of the
Actimab-A Phase 2 trial and Iomab-B pivotal Phase 3 SIERRA trial. Greg’s
direct experience in AML and significant knowledge of clinical trial
management will have an immediate impact on our capabilities that we
expect will add efficiency and scale to our current and planned clinical
development efforts.”

Most recently, Mr.
Bergonio worked at Novartis as an expert clinical manager in their
oncology global development unit with a focus on acute myeloid leukemia
(AML). At Novartis, Greg managed a wide array of clinical development
activities focused on driving effective operations at clinical trials
sites on an international basis. In addition, he coordinated
interdisciplinary efforts focused on inspection preparation activities
associated with the new drug application (NDA) submissions at the site
and sponsor level. Prior to Novartis, Greg worked at a number of large
multi-national pharmaceutical companies and CROs including Bausch &
Lomb, OSI, Forest Laboratories, Inc. and Kern McNeill International
where he gained experience in the therapeutic areas of oncology,
cardiology, CNS and ophthalmology. Greg has a Master of Science Degree
in Health Sciences with a focus on Clinical Research Administration from
George Washington University and a Bachelor of Science Degree in
Nursing from Fairleigh Dickinson University.

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com)
is a New York-based biopharmaceutical company developing innovative
targeted therapies for cancers lacking effective treatment options.
Actinium's proprietary platform utilizes monoclonal antibodies to
deliver radioisotopes directly to cells of interest in order to kill
those cells safely and effectively. The Company's lead product candidate
Iomab-B is designed to be used, upon approval, in preparing patients
for a hematopoietic stem cell transplant, commonly referred to as bone
marrow transplant. A bone marrow transplant is often the only potential
cure for patients with blood-borne cancers but the current standard
preparation for a transplant requires high-dose chemotherapy and/or
total body irradiation that result in significant toxicities. Actinium
believes Iomab-B will enable a faster and less toxic preparation of
patients seeking a bone marrow transplant, leading to increased
transplant success and survival rates. The Company is currently
conducting a single pivotal 150-patient, multicenter Phase 3 clinical
study of Iomab-B in patients with relapsed or refractory acute myeloid
leukemia (AML) age 55 and older. The Company's second product candidate,
Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2
trial for patients newly diagnosed with AML age 60 and over. Actimab-A
is being developed to induce remissions in elderly patients with AML who
lack effective treatment options and often cannot tolerate the
toxicities of standard frontline therapies. Actinium is also utilizing
its alpha-particle immunotherapy (APIT) technology platform to generate
new drug candidates based on antibodies linked to the element
Actinium-225 that are directed at various cancers that are blood-borne
or form solid tumors.

Actinium
Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a
biopharmaceutical company developing innovative targeted therapies for
cancers lacking effective treatment options, announced today that it has
issued a letter to shareholders highlighting the Company’s
accomplishments in 2016 and anticipated milestones for 2017.

The Phase 3 pivotal trial dubbed the SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML)
trial for Iomab-B was initiated in 1H:2016, as forecasted, representing
a major step forward for this program given the manufacturing issues
that were a key focus in 2015.

Significant enthusiasm for
Iomab-B and the SIERRA trial was seen at our Investigator Meeting in
July with continued participation interest post-meeting from most of the
leading bone marrow transplant (BMT) centers.

Orphan Drug Designation awarded for Iomab-B in the US and the EU with potential regulatory, financial and marketing incentives.

Initiated
pursuit of Scientific Advice for Iomab-B from the European Medicines
Agency (EMA) to explore regulatory pathway in the EU and awarded
preferential Small and Medium-Sized Enterprise (SME) status providing
enhanced support from regulators.

Expected prominent position in
major peer reviewed scientific publication and outreach program at the
American Society of Hematology (ASH) annual meeting will continue to
drive interest for Iomab-B and the SIERRA trial.

Results
from an analysis of the two Actimab-A Phase I trials in our
HuM195-Alpha program showed that Actimab-A was well tolerated amongst
patients who have few treatment options due to the toxicity of
chemotherapy and also had promising efficacy.

A key discovery
made while analyzing these trials was that patients with high levels of
immature white blood cells or Peripheral Blasts (PBs) had lower
treatment response rates than those with lower PB’s. This finding gave
rise to the PB Burden Hypothesis which postulates that PB levels are
predictive of, and inversely correlated with patient responses to
Actimab-A.

The ongoing Phase 2 trial stipulates low PB burden
below a key threshold as an inclusion criteria with use of hydroxyurea
mandated to lower PB burden where necessary in order to maximize the
addressable patient population.

Importantly, the Phase 2 PB
burden threshold corresponds to a response rate of fifty percent at
equivalent dose levels in the Phase I trials. If these results are
replicated in the ongoing Phase 2 they will imply that Actimab-A with
its benign safety profile and relatively simple regimen and route of
administration is a best in class treatment compared to other CD33
programs.

Activity
related to strengthening the intellectual property remains robust with
key patents being filed and notices of allowance being received this
year for Iomab-B, Actimab-A and the platform.

Orphan drug
designation for Iomab-B in the U.S. and EU was achieved this year as
mentioned earlier. Pursuit of orphan designation in the EU for
Actimab-A is expected imminently.

An independent analysis
indicates the EU market for Iomab-B is larger than the U.S. market with a
favorable reimbursement outlook and the company has begun exploring
regulatory approval strategies.

Key managerial hires were made
in the supply chain, quality control and clinical development areas to
support the expanded clinical development and pipeline expansion
activity expected going forward.

Positive Outlook for 2017 and Beyond

Efficiently
execute on the pivotal Phase 3 SIERRA trial to reach the first
independent Data Monitoring Committee (DMC) report at 25% of enrollment
by 1H:2017, 50% and 75% in 2H:2017 and maintain the pace of enrollment
to enable topline results the following year.

Report interim
data from Phase 2 trial for Actimab-A by mid-2017 and explore the
regulatory pathway for a pivotal trial based on this data.

Complete enrollment of the Phase 2 trial by end of 2017 and report top line data results.

Sandesh
Seth, Executive Chairman of Actinium said, “2016 has been a key
transitional year for the Company as Iomab-B began the pivotal Phase 3
SIERRA trial and Actimab-A began a Phase 2 trial underpinned by
promising Phase 1 results. In addition, we focused on building a
foundation for the future with key hires, expansion of our intellectual
property portfolio, execution of key regulatory pathways and by
bolstering our balance sheet. We look ahead to 2017 with great
excitement as we expect to have data for both of our clinical trials
which we believe will validate their potential and serve to unlock
value.”

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com)
is a New York-based biopharmaceutical company developing innovative
targeted therapies for cancers lacking effective treatment options.
Actinium's proprietary platform utilizes monoclonal antibodies to
deliver radioisotopes directly to cells of interest in order to kill
those cells safely and effectively. The Company's lead product candidate
Iomab-B is designed to be used, upon approval, in preparing patients
for a hematopoietic stem cell transplant, commonly referred to as bone
marrow transplant. A bone marrow transplant is often the only potential
cure for patients with blood-borne cancers but the current standard
preparation for a transplant requires high-dose chemotherapy and/or
total body irradiation that result in significant toxicities. Actinium
believes Iomab-B will enable a faster and less toxic preparation of
patients seeking a bone marrow transplant, leading to increased
transplant success and survival rates. The Company is currently
conducting a single pivotal 150-patient, multicenter Phase 3 clinical
study of Iomab-B in patients with relapsed or refractory acute myeloid
leukemia (AML) age 55 and older. The Company's second product candidate,
Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2
trial for patients newly diagnosed with AML age 60 and over. Actimab-A
is being developed to induce remissions in elderly patients with AML who
lack effective treatment options and often cannot tolerate the
toxicities of standard frontline therapies. Actinium is also utilizing
its alpha-particle immunotherapy (APIT) technology platform to generate
new drug candidates based on antibodies linked to the element
Actinium-225 that are directed at various cancers that are blood-borne
or form solid tumors.